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October
3, 2000
Company
Press Release
Galileo Laboratories
Expands Senior Management Team, Adding Nutritional Discovery and
Clinical Development
Galileo Names
Robert A. Lunbeck, Jr. as Chief Financial Officer, Stephen D. Phinney,
M.D., Ph.D., as Vice President Clinical Nutrition, and Sekhar S.
Boddupalli, Ph.D., as Vice President Nutrition Discovery
Santa
Clara, CA, October 03, 2000 – Galileo Laboratories, Inc. has
expanded its senior management team as the company advances its
Nutritional Discovery and Development programs. This effort will
operate alongside Galileo’s Pharmaceutical programs.
Galileo
has appointed Robert A. Lunbeck, Jr. as Chief Financial Officer.
In this position, Mr. Lunbeck is responsible for directing Galileo’s
finance activities, investor relations, and planning for the company’s
anticipated high growth. Mr. Lunbeck joins Galileo from Chase H&Q,
a leading investment bank, where he spent four years as Senior Healthcare
Analyst. Previously, Mr. Lunbeck served as Analyst specializing
in healthcare at RCM Capital Management, a San Francisco based institutional
money manager, and as Vice President, emphasizing biomedical investing,
at Security Pacific Venture Capital. Mr. Lunbeck holds an MBA from
Stanford University and an A.B. in Economics, Phi Beta Kappa,
from Harvard College, and is a Chartered Financial Analyst.
Stephen
D. Phinney, M.D., Ph.D., joins Galileo as Vice President Clinical
Nutrition. Dr. Phinney develops and manages clinical trials for
Galileo’s Nutrition programs. Dr. Phinney brings 20 years
of design and clinical trials experience in both academic and industry
settings. Over 55 of his peer-reviewed publications have appeared
in both clinical nutrition and biochemical journals. “Dr.
Phinney’s credentials, expertise, and track record will allow
Galileo to efficiently conduct state-of-the-art clinical studies
incorporating genomics and wireless applications. This competency
will greatly advance the development of personalized, bioactive
consumer nutrition products that are evidence-based and exceed current
regulatory standards," said Guy Miller, M.D., Ph.D., Chief
Executive Officer of Galileo. Dr. Phinney holds an M.D. from Stanford
University Medical School and a Ph.D. from MIT in Nutritional Biochemistry.
He completed a Clinical Nutrition fellowship at Harvard Medical
School, and subsequently held clinical faculty appointments at MIT,
University of Vermont College of Medicine, University of Minnesota,
and as Professor at the University of California at Davis.
Also
joining the Galileo senior management team as Vice President Nutrition
Discovery is Sekhar Boddupalli, Ph.D. Dr. Boddupalli comes from
Monsanto Company where he was Director, Human Nutrition. After completing
his training in biochemistry at the Indian Institute of Science
in Bangalore, Dr. Boddupalli held faculty appointments at the University
of Texas, Southwestern Medical Center, Dallas.
About Galileo
Laboratories
Galileo
Laboratories discovers and develops proprietary nutritional and
pharmaceutical products to address such major chronic conditions
as cardiovascular disease and diabetes through mitigating metabolic
and oxidative stress. Galileo deploys state-of-the-art pharmaceutical
and biotechnology tools to screen and develop bioactive compounds
for use as functional foods, complementary medicines,
and pharmaceuticals. The company possesses proprietary cell-based
technology that models the human metabolism, allowing for rapid
screening and isolation of therapeutically beneficial compounds,
dramatically speeding time-to-market. Galileo clinical studies provide
credible evidence of safety and efficacy. Galileo has strategic
product development agreements with leading companies in biotechnology,
pharmaceuticals and consumer products. This spring, Nutraceuticals
World named Galileo, along with McNeil/J&J, General Mills
and Quaker Oats, as one of the industry’s top 10 innovators.
Contact
Peter
Leighton, Vice President Marketing
Galileo Laboratories, Inc.
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For patients receiving ceftriaxone in a dose of ≥40 mg/kg body weight/day or a dosage of ≥20 mg/kg daily for ≥3 months (≥4 times the maximum recommended dose) for treatment of MRSA, patients should undergo an additional clinical trial of ceftriaxone to determine an acceptable daily dose if not determined by the FDA (FDA, 2014b).
Special Considerations
Patients Receiving Metronidazole
Metronidazole should not be used alone or in combination with other antibiotics to treat MRSA infections unless the indication specifically requires this combination, or the benefits of combination outweigh risks the medications (Table 8; CDC, 2016).
Patients in Respiratory-Related Conditions (eTable-4)
In cases where an infection is suspected or where an individual has a history of respiratory disease, antimicrobial exposure should be restricted. If an appropriate alternative antibiotic or therapy is needed for a patient with suspected or active respiratory system infection, the antimicrobial should be discontinued unless it is determined that not required because of the patient's illness or medical conditions.
Patients with Respiratory Syndrome (eTable-5)
Patients with a history of suspected or active respiratory syndrome requiring antimicrobial therapy (such as pneumonia, pneumonia with or without pleural effusion, bronchitis, acute exacerbations of asthma, or asthma-related pulmonary function tests within the previous 2 weeks) may consider a reduction in total daily dose of any antimicrobial used with such an episode. For patients who need antimicrobial therapy, this should be considered only in patients whose underlying illnesses are stable on normal therapy (eTable-5).
Special Consideration Considerations for the Elderly
Elderly patients may have compromised immune systems. As a result, antimicrobial therapy should be administered only in patients whose condition warrants antimicrobial therapy. Elderly patients are more likely to have chronic liver disorders that decrease their effectiveness of antimicrobial therapy (CDC, 2016). Patients aged 65 and older who receive antimicrobial treatment should the usual adult dose (eTable-5). In addition, elderly, debilitated patients receiving antibacterial therapy should be observed closely and receive a reduction of the total daily dose if possible. For elderly patients with compromised renal function, the dose reduction may be appropriate. For patients receiving metronidazole, this may be as high 0.1 mg/kg if the clinical significance Divalproex generic price of their illness or clinical situation is uncertain; otherwise, a reduced dose should be administered (eTable-5, also see FDA Guidance for Antimicrobial-Use in Pregnant Women and Children, available at http://www.fda.gov/cder/Drugs/default.htm, on the date of this guideline) (eTable-5).
For patients receiving ceftriaxone treatment a suspected or active bacterial respiratory infection, the total daily dose of ceftriaxone may be reduced at the discretion of treating physician for patients receiving any antimicrobial (eTable-4). Decreases in total daily dose or dosage intervals should be made cautiously for patients on antimicrobial-containing therapy or for patients with liver disease and whose renal function is compromised or for patients under the age of 65.
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For patients receiving antimicrobial treatment as part of a respiratory-related bacterial infections management and care plan, treatment adjustments (eTable-4) should be made in accordance with the guidelines of an ACAM task force (ACAM, 2011).
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Infants, children, and pregnant women may have altered susceptibility to antimicrobial agents. For these patients, appropriate adjustment of the daily dose and/or dosage intervals of antimicrobial agents may be necessary (eTable-5). A reduced dose should be administered in such instances. If a reduction or interruption (or combination with antimicrobial treatment) is necessary, clinicians should discuss this with the treating physician to assess whether the patient will need antimicrobial drug regimens that are different than those they started on. A reduction or interruption in the total daily dose of any antimicrobial may need to be made if the total daily.
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